Delestrogen Side Effects

Brand Names: Alora, Estrasorb, EstroGel, Femring, Evamist, Femtrace, Menostar, Depo-Estradiol, Climara, Elestrin, Estraderm, Estrace, Vivelle, Vivelle-Dot

Please note - some side effects for Delestrogen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Delestrogen - for the Consumer

Delestrogen

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Delestrogen:

Abnormal hair growth; breast tenderness; changes in sex drive; cramps; dizziness; flushing; hair loss; headache; lightheadedness; nausea; pain, swelling, or redness at the injection site; reduced tolerance to carbohydrates; stomach bloating and upset; swelling; vaginal infection; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; calf pain or tenderness; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in vision or speech; chest pain; confusion; coughing of blood; mental/mood changes (eg, depression, memory loss); numbness of an arm or leg; one-sided weakness; pain, swelling, or tenderness in the stomach; problems with contact lenses (eg, changes in fit); severe headache, dizziness, fainting, or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness of an arm or leg; yellowing of the skin or eyes.

Delestrogen Side Effects - for the Professional

Delestrogen

See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

1.

Genitourinary system
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
 

2.

Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
 

3.

Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
 

4.

Gastrointestinal
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
 

5.

Skin
Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
 

6.

Eyes
Retinal vascular thrombosis; intolerance to contact lenses.
 

7.

Central Nervous System
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
 

8.

Miscellaneous
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

Side Effects by Body System

Gastrointestinal

Cases of oral pigmentation and ischemic colitis have been reported rarely.

Gastrointestinal side effects have included nausea, abdominal cramps, bloating and vomiting. Some studies have demonstrated a 2 to 4 fold increase in gallbladder disease in postmenopausal women taking estrogen therapy. Cholestatic jaundice, pancreatitis, and enlargement of hepatic hemangiomas have been reported. Post marketing experience with the vaginal ring has included a few cases of bowel obstruction and vaginal ring use.

Oncologic

Oncologic side effects have included reports of an increased risk of endometrial carcinoma in patients with an intact uterus and less persuasively, with an increased risk of breast cancer.

A number of studies have suggested that the risk of endometrial carcinoma is removed (or delayed) by the administration of progestins in combination with estrogen therapy.

The increased risk of breast cancer due to use of estrogens is controversial. Several studies have suggested that long-term estrogen therapy may be associated with a slightly increased risk of breast cancer. Meta analysis of 51 studies (epidemiological data) supports a modest risk increase associated with long-term hormone replacement therapy (HRT).

One study of Swedish women has reported that a 10% increase in the relative risk of breast cancer may occur and that the risk is related to increasing duration of estrogen therapy. In that study, women with more than nine years of estrogen use had a 70% greater relative risk of breast cancer than controls. That study, however, examined use of a variety of estrogen preparations of which estradiol was the most frequently prescribed. In addition, women who took progestins did not demonstrate a decreased risk of breast cancer and may even have been at higher risk.

The Toronto Breast Cancer Study has reported that women who receive unopposed conjugated estrogens for less than 15 years are not at increased risk of breast cancer. In that study, an increase in the risk of breast cancer for women who used conjugated estrogens for more than 15 years was not ruled out.

The Case-Control Surveillance Study has reported that there is "no evidence that the use of unopposed conjugated estrogens increases the risk of breast cancer, even after long duration of use or long latent intervals, but the possibility of a modest increase (less than a doubling) could not be excluded."

Follow-up to the Nurses' Health Study of 1992 concluded, however, that there is an increased risk of breast cancer in women taking estrogen replacement therapy and that the risk is not reduced by concurrent use of progestins. (In that study, greater risk was associated with advanced age and prolonged duration of hormonal therapy.)

A study of middle-aged women in the Puget Sound area concluded that "on the whole, the use of estrogen with progestin HRT [hormone replacement therapy] does not appear to be associated with an increased risk of breast cancer in middle-aged women."

A prospective cohort study (11 years) of 37,105 women by Gapstur et al evaluated the histology of the breast cancer in women who ever used HRT. No association was found between duration of ever HRT use and the incidence of ductal carcinoma in situ or invasive ductal/lobular carcinoma. The duration of ever HRT use was associated with risk of invasive carcinoma with a favorable prognosis (relative risk (RR) = 1.81, 95% confidence interval (CI), 1.07 to 3.07 for HRT use less than or equal to 5 yrs and RR = 2.65, CI, 1.32 to 5.23 for HRT use > 5 yrs, p = 0.005). The relative risk of invasive carcinoma with a favorable prognosis for current users (adjusted for age and other risk factors) was 4.42, CI, 2.00 to 9.76 for less than or equal to 5 yrs and 2.63, CI, 1.18 to 5.89 for > 5 yrs). Risk of invasive ductal or lobular carcinoma for current users less than or equal to 5 yrs was RR = 1.38, CI, 1.03 to 1.85.

Cardiovascular

The reported effects of estrogens on cardiovascular activity are variable. Alterations in lipid profiles in treated women are thought to be responsible for reducing cardiovascular risks. Data suggest estrogen use may increase blood pressure, particularly in patients receiving high doses, decrease blood pressure, or result in no change. In addition, noncontraceptive use of estrogens in young women (particularly smokers) may substantially increase the risk of nonfatal myocardial infarction. Other studies have concluded that no increased risk of myocardial infarction exists.

Cardiovascular side effects have included studies suggesting that unopposed estrogen therapy decreased the risk of coronary heart disease by as much as 35%. Combination therapy with a progestin may have also decreased coronary risk. However, the extent of risk reduction with combination therapy has not been determined. Data are available that suggest combination therapy does not reduce the overall rate of coronary heart disease in postmenopausal women with established coronary disease.

Metabolic

Metabolic side effects have included reports of generally favorable alterations in plasma lipid profiles. Specifically, increased HDL and decreased cholesterol and LDL levels have occurred. Estrogen therapy may have led to increased serum triglyceride levels resulting in pancreatitis in patients with familial lipoprotein metabolic defects.

Metabolic adverse effects such as hypercalcemia have occurred in patients with breast cancer and bone metastases.

Endocrine

Endocrine side effects have included increased levels of thyroxin-binding globulin which led to increased total thyroid serum levels and a decreased in resin uptake of T3. Free thyroid hormone levels remained unchanged. Other endocrine effects have included decreased fasting plasma glucose.

General

General side effects have included fluid retention and mastodynia. Alterations in libido have occurred. Post marketing experience with the vaginal ring has included a few cases of toxic shock syndrome.

Hepatic

Many of the reports of hepatic tumors have occurred in women taking long-term oral contraceptives. However, some tumors have been reported in women taking isolated estrogen therapy.

Hepatic side effects have included reports of focal nodular hyperplasia, liver cell adenomas, hepatic hemangiomas, and well-differentiated hepatocellular carcinomas. Aggravation of porphyria has been reported.

Hematologic

Hematologic side effects have included hypercoagulability and an increase in venous thromboembolism.

The clinical significance of such hypercoagulability in postmenopausal women taking estrogens has not been determined.

Ocular

Ocular side effects have included alterations in corneal curvature and contact lens discomfort. Retinal vascular thrombosis has been reported.

Hypersensitivity

Hypersensitivity side effects have included reports of reactions including anaphylaxis. Some reports have implicated the dyes contained in some conjugated estrogen formulations. Urticaria and angioedema have also been reported.

Other

Other side effects have included reports of a possible increase in the risk of "fibrocystic breast disease" by as much as twofold.

Psychiatric

Psychiatric side effects have included case reports of rapid mood cycling in patients with severe depression.

Nervous system

Nervous system side effects have included dementia, dizziness, mental depression, headache, nervousness, irritability exacerbation of epilepsy and new onset or exacerbation of migraine headaches. A case of chorea has been reported in association with estrogen therapy.

Dermatologic

Dermatologic side effects have included chloasma or melasma, which did not always resolve following discontinuation of estrogen therapy. Scalp hair loss, hirsutism, erythema nodosum, and hemorrhagic eruptions have occurred.

Genitourinary

Genitourinary side effects have included abnormal uterine bleeding and dysmenorrhea. In some cases, this was bleeding related to endometrial carcinoma. In addition, estrogens have increased the size of preexisting uterine leiomyomata. Post marketing experience with the vaginal ring has included a few cases of ring adherence to the vaginal wall, making removal difficult.

Musculoskeletal

Musculoskeletal side effects have included arthralgias.

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